Mifepristone Tablets 10 mg
Read the leaflet carefully before using.
Keep this medicine out of the sight and reach of children.
Immediately notify your doctor or pharmacist of adverse reactions encountered when using medicine.
INGREDIENTS AND CONTENT
Each tablet contains:
Mifepristone (micronized form) .....................10 mg
Excipients just enough: Silica K200, copovidon, microcrystalline cellulose 102, magnesi stearat.
DESCRIPTION ABOUT PRODUCT
Tablets are light yellow, rounded, beveled, 2 flat surfaces, smooth, one surface with “H” word, the other with grooves, intact edge and walls.
Box of 1 blister x 1 Tablet.
Pharmacological group: Progesteron antagonists.
ATC Code: G03XB01
Mifepristone is a synthetic steriod that acts a progesterone antagonists by competing with the receptor for endogenous progesteron receptors. Medicine binds very strongly to this receptor (2 to 10 times the progesteron). The emergency contraceptive mechanism of mifepristone includes:
- Fertility suppresses follicular function as well as suppresses the endocrine fuction of granulosa cells, so patients will be less likely to ovulate if given the drug before ovulation.
- The drug breaks the peak of LH in the middle of the cycle, thus inhibiting ovulation.
- If taken at the end of the cycle, the drug interrupts endometrial support by the hormone, creating an asynchronous cavity in the endometrium, leading the degeneration and peeling of the endothelial lining, which in turn prevents and inhibits the fetal attachments to the uterus.
After oral administration, peak plasma concentrations of mifepristone were reached after 1.3 hours. About 70% availability. The elimination include two-phase, slow-phase is followed by a faster phase with a half-life of about 18 hours. Mifepristone is metabolized by the liver, the metabolites are excreted in the bile and excreted in the feces. Ony a small amount of the drug is found in the urine. Mifepristone binds to plasma proteins about 98%, predominantly with α1-glycoprotein acid.
Mife 10 is indicated for emergency contraception within 120 hours after unprotected intercourse.
DOSAGE AND ADMINISTRATION
Mife 10 is taken orally.
Take 1 Mife tablet 10 within 120 hours after sex. However, use as soon as effective.
Contraindicated use of Mife 10 in the following cases:
- Hypersensitivity to mifepristone or any of the other ingredients
- Chronic adrenal hyperplasia
- Severe asthma is not controlled
- Kidney failure or liver failure
- Hereditary porphyrin
- Breastfeeding woman
CAUTIONS AND RECOMMENDED WHEN TAKING MEDICINE
- Emergency contraception is a emergency measure that can oly be used in emergencies and is not a substitute for regular contraception. People who use emergency contraception many times should consider using long-term contraception.
- The method of emergency contraception can not achieve the desired effect in all cases. If you are not sure about the duration of unprotected sex of if woman has had an unprotected sex for more than 120 hours in the same menstrual cycle, you may be pregnant. Therefore, treatment with mifepristone 10 mg after second intercourse may not have a contraceptive effect. If the menstrual period lasts more than 5 days, or bleeding is unusual on the expected menstrual period or pregnancy is suspected for any other reason, the patient must be determined not to be pregnant.
- Unprotected intercourse after treatment may increase the risk of unintended pregnancy.
- Do not repeat the same cycle because it can cause menstrual disorders.
- It should be used with caution in patients with less severe asthma or chronic obstructive pulmonary disease, hemorrhage, cardiovascular disease or related risk factors, anemia.
- It should be used with caution in patients on long-term treatment with corticosteroids; Corticosteroids may be used if acute hyperplasis is suspected.
- Caution should also be exercised in patients taking anticoagulants as it may increase the risk of severe bleeding.
Do not use drugs for pregnant women and drugs do not have the effect of abortion.
A dose of 10 mg is not enough to cause a miscarriage, but it can not be excluded that bleeding may occur in some cases if the woman is pregnant.
Mifepristone can be excreted in milk of mother. Because mifepristone effects on children are not known, breast-feeding women should consult a physician to decide whether to clear breast milk for few days after taking the drug.
Ability to drive and operate machines
Impact on the ability to drive and operate machines is unknown. In the case, patients with headaches should be careful when driving or operating machinery.
Do not take aspirin and NSAID together with mifepristone because theoretically prostaglandin synthase inhibitors can alter the effect of mifepristone.
Very common: Nausea, lower abdominal pain .
Common: Vomiting, diarrhea, mild or moderate cramps.
Skin and subcutaneous tissue disorders
Uncommon: Hypersensitivity, rare skin rash.
Rare: Urticaria, redness of the body, pinky, necrotic lesions (TEN).
Very rare: Angioedema
Less: Lower blood pressure.
General disorders and on-site
Very common: Tired
Rare: Irritability, hot flushes, dizziness, chills, fever.
Breast and reproductive system
Very common: Menstrual cycle is deviated in 2 days (over 50%). Hemorrhage.
Common: Chest pain, delayed menstruation over 7 days (9%).
HOW TO HANDLE ADR:
Less and mild side effects, symptomatic treatment if needed.
If allergic reactions occur, such as rash, urticaria, angioedema, immediate treatment with adrenaline, glucocorticoid, antihistamin and never treated with mifepristone.
Support fluid and electrolyte balance when toxic epidermal necrolysis occurs, antibiotics are used to protect against infection.
Supportive treatment against the effects of bleeding, including gastrointestinal bleeding Observe the risk of pulmonary edema and acute respiratory distress syndrome. Anticoagulant therapy with 5000 heparin subcutaneous injection 3 times/24 hours. Pain relief and tranquilizer. Treatment of high fever.
OVERDOSE AND TREATMENT
Dose studies showed that the administration of a single dose of mifepristone to a total dose of 2g did not appear to have an undesirable effect. In all cases of acute poisoning, patients should be hospitalized for follow-up and supportive treatment in special conditions.
Store in a cool, dry place, temperature below 30oC.
24 months from manufacturing date.
Batch number (Batch No.), date of manufacture (Mfg. date), expired date (Exp. date): please seen on the lable of packaging.
HERA BIOPHARMACRUTICAL CO. LTD.
Lot A17, Tu Ha Industrial zone, Tu Ha Ward, Huong Tra Town, Thua Thien Hue Province, Viet Nam.